Good morning, everybody. I'm Tycho Peterson with the Life Science team. It's my pleasure to introduce Veracyte. We've got Marc and Rebecca with us today. Welcome to you both. Maybe, Marc, just to kick it off, we could do a little bit of a look back on 3Q: strong revenues, strong EBITDA margin expansion, your raised revenue and profitability guidance. Maybe just talk about some of the momentum heading into year-end and into next year.
Yeah, thanks, Tycho. Happy to, and thanks for having us here. Before I get into that, I'd just like to remind everybody about our Safe Harbor statement. You can find the full text of that to the extent we're going to be making forward-looking statements. You can find the full text of that on our website at www.veracyte.com. To get into your question, thanks for the opportunity to talk about, to me, what was, frankly, just a fantastic quarter. The company performed on all levels, but to me, it just adds another quarter to many, many quarters, I think, of exceptional performance by the Veracyte team. The growth in the quarter was fantastic. The total company grew 14% year-over-year.
If you adjust for, just look at the testing business and adjust for a portfolio decision we made around the Envisia test, our testing business grew 18%, led by our class-leading Decipher test and our long-standing Afirma test. If you think about Decipher and Afirma, they both grew fantastically in the quarter. Decipher grew 26% in volume, marking the 14th quarter of more than 25% growth for that product, and demonstrating that we're still very much in the early innings of penetrating the prostate cancer market from a diagnostic standpoint. Afirma had volume growth in the quarter of 13%, actually marking the 13th quarter of growth in volume for that product, a product that has been on the market, as I say, for quite some time. I couldn't be more proud of our team.
To really kind of put the icing on the cake as far as the quarter is concerned, we had an adjusted EBITDA margin of 30%, which I think it was maybe about six quarters ago, I predicted that a business in this space that is well-run and operating effectively could generate an adjusted EBITDA of about 25%. I would say we hit that more than a year earlier than we anticipated, which I think is great news. That sets the bar for an ongoing annual EBITDA margin of around 25%, which we think is both sustainable and appropriate.
Maybe just thinking ahead to 2026, without kind of going directly to numbers, talk about some of the milestones we should be paying attention to, whether it's clinical readouts, coverage expansions.
Yeah, I've been really excited, actually, by the pipeline that we have. I mean, if I actually just talk about that core business for a second, that core business has fueled our ability to create new opportunities for the company. We launched a metastatic test, for example, for prostate cancer this year. We launched a new platform in our lab that will be extensible for products going forward. If I look forward to 2026, as you asked, we've got an exciting portfolio of products coming. We've got our MRD test launching sometime in the first half. We have an MRD platform that is a differentiated whole genome approach, and we'll be launching that first in a muscle-invasive bladder cancer indication. That is a market where we already have the channel, or at least the majority of the channel.
We're looking forward to that test being kind of the first in a series of MRD tests that Veracyte will launch. In addition, in the middle of next year, we're planning to launch our Prosigna test as a lab-developed test for the U.S. market, addressing a market of about 225,000 patients on an annual basis here in the U.S., or not here in the U.S., but in the U.S. I forgot we're actually in the U.K. right now. I mean, super excited about that. We're also advancing our international strategy and developing several of our tests on new platforms for launch outside the U.S.
One last thing to add in there. We'll have a full year of our updated transcriptome as well. For those of you who are unaware, we have moved from an older generation sequencing instrument to a newer generation sequencing instrument for our Afirma platform, and that will effectively allow us to invest incrementally quite significantly given reduced costs. That will have, effectively from January 1, every Afirma sample will be run on that new transcriptome.
Marc, you touched on the strong Decipher growth you had in 3Q, both revenue and volume. Maybe just talk about the momentum there, how you think about durability.
Yeah, we're very excited about Decipher and both where we've got to with the product and where it's going. I think about the tailwinds that are going to drive ongoing Decipher growth. Maybe just let's talk about the penetration in the marketplace and our position. As we came into this year, if you do the math, we had about 25% of the addressable market, which in the U.S. is about 300,000 patients. The incidence rate is growing in the single digits, unfortunately. From a market share standpoint, we estimated we had about 65% of the share. If you think about it in that respect, 25% of the market is penetrated by Veracyte. We address the entire spectrum of risk from low, intermediate, high into metastatic, RP. Every one of those patients over time could potentially benefit from the Decipher test.
There is 75% of the market out there to be addressed by us potentially. That is exciting. That demonstrates that we are still very early on in the innings here. What is really driving and fueling that growth is the evidence, as it does for everything in our market. We have 240 or so publications around Decipher. We have level one NCCN Guidelines in intermediate and high in RP. I think over time, obviously, we potentially get level one guidelines in low and in metastatic. There is a lot of benefit there. One of the reasons that Decipher, I think, has been so successful is as a company, philosophically, we take a data-leading approach.
We test or generate an entire transcriptome, and then that is able to be used to fuel future research to help understand better the impact of prostate cancer on patients and how testing can be used to differentiate one patient from another patient and truly personalize the approach. That is why we have so many publications, or one of the reasons we have so many publications behind Decipher, which is great for patients. The entire Veracyte team is driven by the mission to support patients. Patients are our purpose, and we really focus on what's best for the patient.
You mentioned NCCN. I guess, what steps are you taking to expand the guidelines for low and metastatic, and how much of a lift could that give you?
Yeah, and let's be clear. I mean, guidelines for localized level one and us getting that NCCN level one designation only happened a few years ago, and we were growing nicely even up until that point. As I mentioned, Decipher's grown 25% for 14 quarters in a row or more. While guidelines help kind of move into a higher rate of growth, I think, it's not entirely necessary. We're growing in low, and we expect to grow in metastatic, but guidelines will give that boost. The publications take a long time. The studies take a long time. Sometimes you have to have started a decade ago, and many have. Over time, we expect those publications to come out. We had a great publication in metastatic last year called STAMPEDE. That's one, I think, of many.
That will certainly be enough to encourage physicians to use a test or some physicians, whether it's enough to get into NCCN Guidelines to be determined, but there'll be other studies in the future.
We recently had a guideline update just here a couple of weeks ago that was quite favorable as well. I think when it comes down to it, these are released periodically every three to four quarters. In each and every one over the last three or four years, Decipher has become even more powerful and in an even more powerful position. I fully agree with Marc that just kind of the rinse and repeat of guideline advancement is something that's core to our philosophy and engagement from a discovery perspective.
Can you maybe talk more on the halo effect you're seeing in high-risk localized prostate cancer? In other words, what messaging to docs is resonating, and what's the average time from first contact to routine ordering for physicians?
Yeah, I mean, the second part of that, the average time, of course, is there is across the board depending on patient. But I think what we've and physician, what we've seen lately is as the high-risk or metastatic conversation has been had with physicians and the STAMPEDE data has been shared, part of that data also included very high-risk patients and the benefit of the Decipher test for those patients as well. That has really fueled that new conversation in high risk. Last quarter, high risk was one of our best growing areas at about 30%. It is also one of the lower penetrated parts of the risk spectrum. I think those are encouraging signs that physicians are now starting to think about those patients and how they can use diagnostic testing to differentiate the treatment plan.
I think we're seeing the early stages of that yet. It's too early to call it a trend, but I think it's something for us to watch for going forward.
Maybe we can touch on ASPs and talk a little bit about what you're expecting for ASP lift with metastatic for Decipher and how you anticipate that mix evolving.
Yeah. Over time, I think you aren't going to materially see a difference between the Decipher Prostate ASP and the metastatic ASP. They're reimbursed at the exact same rate. Prostate has a slightly higher Medicare population than metastatic than in the localized disease, but it's around the edges. I think ASP is less driven by the metastatic population and more driven by incremental coverage and contract decisions with commercial payers. We are at 200 million covered lives today. If you fast forward the clock five years from now, we should be closer to 250 or 275, which would lend itself to maybe a 300-500 roughly basis point accretion to ASP over that five-year period. There is room on ASP for Decipher. The team is doing a great job getting new contracts and new coverage.
In any given year, what that is is to be determined because of the timing of those where we can't necessarily forecast perfectly given we only control 50% of that equation.
Any concerns around, I mean, PAMA as a perennial overhang or MolDX?
Yeah. On the PAMA front, our codes will be analyzed to be reset in 2028 for reset in 2029. We do the analysis each and every year to see what that would mean. At this point in time, it would not change our reimbursement rate. Today we are fine. We are obviously very cognizant of PAMA. When we sign new contracts, we make sure that we are getting paid appropriately.
Maybe just connecting some of the dots, we talked about guidelines. We talked about your strong share position. I guess, how much do clinicians value the importance of the NCCN rating from a kind of market perspective?
I think they do value it. As I said earlier, we saw strong adoption, good growth even without the NCCN guidelines. There are examples of physicians who were using Decipher for every patient even before guidelines recommended that you do so for those intermediate and high risk and RP. I think there's every category of physician out there from the physician who will adopt the test for every single patient to the physician who will use it only in intermediate cases. Guidelines and new studies and publications start to drive those physicians to use it more broadly across the spectrum to those who will not use molecular diagnostics at all unless and until guidelines really very clearly tell them to in those cases. I think you're still going to have physicians who do not follow the guidelines, of course.
I think it's just the way we look at it is evidence drives guideline inclusion. And together, evidence and guidelines help drive adoption. That's how we ultimately get to penetrate a significant portion of the market.
Has that share shift accelerated though, given the issues one of your competitors, maybe Rebecca knows, has run into trouble with?
I think it has. I mean, it's hard to tie that specifically to the advantageous position we have in guideline inclusion versus the advantageous position we have in evidence in general. And 240 publications, I think, is close to an order of magnitude higher. It's always difficult to tie it back to any particular cause and effect, which is why we focus on evidence and evidence being the driver of all of these things, including adoption and guideline inclusion. Of course, durable reimbursement, which is important too. It is when there is so much strong evidence behind a test, it becomes much easier to have those conversations with the MACs or with MolDX. It's also easier to have those conversations with commercial payers.
Maybe just talk about the strength of the evidence suite for Prostate for active surveillance, prostatectomy, radiation decision-making.
Yeah. That's always been the challenge in kind of the low risk and the active surveillance population, getting the clinical studies done over time to get level one evidence there. You see a lot of dropout over time, and it can be a long time. There are a number of publications or a number of studies in progress right now. I think ultimately when there is level one evidence there, it's just another boost for that. Having said that, I think we referenced this a couple of quarters ago. We have quite significant penetration in the low risk category, and we have strong growth in the low risk category. Guidelines have not been a barrier to adoption.
On the high risk side, we had the STAMPEDE study, which had a high risk arm. It also showed more recently, we also showed more recently that the biochemical recurrence portion of the RP market incurred very strong data in that portion as well. I think as we moved into RP, RP is actually quite underpenetrated. There also is a portion of the prevalence population there that we are not including in the TAM. That is a whole white field that we can go after over time. I do think high risk BCR and metastatic will have incremental data coming out over the next couple of years. We will really start seeing the predictive nature of those claims be incredibly strong and powerful in driving adoption.
How about the balance trial? Can you just maybe touch on that?
Yeah, the balance trial was really interesting at Astro that talked about this PAM50 signature. For those of you that aren't familiar or anybody who follows the breast market will understand this signature. It's a very well-researched, very well-understood, and scientifically robust signature of 50 genes. We actually have our test for breast cancer, Prosigna, which uses the PAM50 signature. And we have the rights to that. The study was done using PAM50 in prostate cancer. It was very effective in determining what treatment efficacy was for patients with different subtypes, luminal B and non-luminal B. The hazard ratios were incredibly compelling.
This is just another example of what Rebecca referred to as the predictive power here of these signatures and the ability to be able to use the signature to differentiate which patients are going to benefit from a treatment and which patients aren't. Obviously, for those who aren't going to benefit, where the standard of care might be to use that treatment today, you're going to avoid all those potential negative effects, life-changing effects, and also delay in some other different treatment path that might be appropriate for those patients. Very excited about that trial, those results. One thing that demonstrates is, again, the power of GRID and how it can be used to analyze and study and research these different biomarkers. What we do is, over time, we can incorporate those biomarkers and those new signatures into our Decipher report.
We're actually doing that with some molecular features that we're adding, like PORTOS and P10, that we're looking to add next year into our Decipher report. This flywheel just keeps on turning as this evidence gets generated.
Maybe you could just spend a minute on the sales channel. Where are you in terms of build out? How do you feel about rep productivity and scale up from here?
Yeah, we're very impressed even internally with our own rep productivity. We have a very strong sales team. This applies both to Decipher and Afirma, where we have roughly 55 sales reps in both cases. We've probably added on average five reps a year. We've optimized that whole territory assignment and reassignment equation very well. There is an optimal level. One of the questions we always ask is, "Hey, if you had another 10 or 20 sales reps, could we grow even faster and be even more productive?" The answer is no, we're optimizing it where we are. We couldn't be happier with that. Our sales team is incredibly strong, and we do view that as a differentiating factor.
At the end of the day, by giving them evidence and giving them guidelines, that is really what fuels them to be able to go into the position and really talk about the benefit of our test.
You need to kind of build more from here or?
I mean, I think on an ongoing basis, I wouldn't see it that differently from where we've been growing, similar kind of rate.
Yeah. We roughly add around five heads a year to Decipher and maybe two or three to Afirma. Over the time from 2021 to 2025, we've grown the sales team from 35 to 55. Revenue has grown from, I can't remember off the top of my head, but call it $100 million- $300 million. The sales rep productivity has increased astronomically.
We touched a little bit on the competitive landscape, but are you seeing any bundling or pricing pressure from any of the competitors?
No, we don't see that as a factor in our business.
Maybe just touch on the PCR IVD development that's coming out of 2026.
Yeah. Decipher, if you think about the international market, I said 300,000 patients annually here in the U.S., and it's about 500,000 patients annually in Europe, or I should say here in Europe again. It is a bigger market. These patients are not getting the benefit of a molecular diagnostic in the same way that patients in the U.S. now are starting to. We really think it's important to be able to launch our test in the U.S. In Europe, we find the best way to do that is as an IVD kit. We are in the process of developing a PCR-based test for Decipher and getting our IVDR approval. That will enable us to be able to launch the test through core labs and hubs throughout Europe.
Is that a partnership strategy or?
The manufacturing strategy is a partnership strategy, but the actual commercialization will be on us. We already have the commercial team selling Prosigna in Europe today, and they're looking forward to having additional tests in their menu.
Maybe just we can flip over to Afirma. That was up 13%, 17,000 tests this quarter. How much of this is Afirma 2 transcriptome enhancement? Maybe just touch on that.
Yeah, actually, none of it, which is the exciting news. We only really had one month and a third of the tests in that month be tied to the V2 transcriptome. We actually haven't been out talking about the lower no result rate that we saw for that month yet. We want to have more data behind that before we really articulate that further. Really, what was driving that in the quarter was competitive wins. We also had, excuse me, we had a number of competitive wins. In general, the new version of GRID and the existing version of GRID, the new version of GRID will be coming out here shortly. The existing version of GRID has taken over, gained share in number of academic players.
I think when it comes down to it, we have reinvested in this product from 2021 on and really driven new functionality that has allowed for us to continue to drive quite significant growth for a product that's been on the market for 14 years.
I guess what will be different about the new version of GRID? Is there a clinical opportunity there over time, or should we really just think about that as research?
It is definitely research use only today. Similar to Decipher, where we had clinical signatures that we needed to bolster the evidence on before they moved, I'm sorry, research signatures that would then become clinical in nature, we will follow the same formula. There are a number of signatures on Afirma GRID V2 that are not on GRID V1. The opportunity to bolster that evidence is there. As those signatures progress in terms of the evidence generation, they will then move into the clinical functionality of the test. It is a constant flywheel that we have going on. You will have more signatures on V2 than you do on V1.
You're seeing a common theme here, the power of the data strategy I talked about earlier, which is in the case of Afirma as well as Decipher, we're running a whole transcriptome. That's what's enabling this.
Maybe just pricing trends for Afirma and how you're thinking about those evolving over time as you get more coverage.
Yeah, I think Afirma has 275 million covered lives. So it's actually quite strong from a coverage perspective. Our ASP is roughly 82%-83% of the Medicare rate. That's pretty stable. In 2025, we have had some headwinds from prior period collections in 2024, as well as a temporal mistaken change in coverage in 2024 that we effectively had to comp over the course of 2025. On a go-forward basis, I view that as steady, more so than having headwinds or tailwinds associated with it.
Maybe just touch on the Prosigna LDT. You mentioned that in your kind of opening comments and the strategy there.
Yeah, launching that in the first half of next year. It's a test we already own, as I mentioned. We're already selling it in Europe as an IVD on the Encounter platform. We're moving it to an LDT here in the U.S. We'll launch that in a market that's very well established for molecular diagnostics. The conversation is less about why you should use a molecular diagnostic and more about why you should use Prosigna. We believe there will be differentiating evidence coming out for Prosigna in the middle of next year, coincident with our launch of the test.
Why LDT first rather than just the IVD?
In the U.S., the LDT market just makes a lot of sense. You can get the benefit of the scale in the centralized lab. The turnaround time is absolutely as effective as it needs to be. A kitted strategy really doesn't make sense for the US. It makes sense for the OUS because you have much smaller scale in each country.
Prosigna has been an IVD in the United States here for quite some time. There were really only a handful of customers that had enough volume to even justify it on the Encounter, let alone the NovaCX that we're using in our laboratory. I can't imagine a single facility outside of a centralized lab like us that would have that level of volume.
Maybe in the last couple of minutes, we can just hit on True MRD and muscle invasive and talk a little bit about how C2i accelerated the launch, what differentiates you from some of the other whole genome approaches.
Yeah, we've been looking for an MRD asset for quite a while, and we picked C2i because they had a whole genome approach. We believe MRD is obviously a very crowded space, but it's very early in the penetration. We needed a platform, but we needed one that was differentiated and fitted with Veracyte's philosophy around this data strategy. More data drives more insights, which leads to more evidence, which leads to better adoption and guidelines over time. This is a long play for us. We're launching a muscle-invasive bladder cancer first because, as I said earlier, we have the channel. It's mostly our urologist channel that we sell Decipher to that will be able to position True MRD in muscle-invasive bladder. We'll launch a new indication. Our plan is to launch a new indication every year. We haven't said exactly what indications yet.
It is a platform. The whole genome really matters because if you imagine having that longitudinal data for every patient episode, every patient interaction where you draw blood, you run a whole genome, and that data will be available. We think that will follow a similar playbook to Decipher. It will fuel research, especially around MRD, and it will help drive more evidence for the test.
How about kind of integrating that into the urologist and oncologist kind of treatment algorithms, right, given the reliance on imaging?
Yeah, the test has already been demonstrated to detect recurrence a lot earlier than imaging. I think that's the selling point for both the physician and the patient is with this much of a lead time of detection, it makes absolute sense. I think we're seeing one of the benefits of this being a crowded market is we're seeing the benefit of the rising tide. People are really starting to appreciate why MRD is so important in cancer treatment. We get to draft on that very important point.
Should we ultimately think about this as a standalone or being bundled? What can you say on ASPs?
We can't say anything on the ASPs yet. We are in discussions with MolDX. First comes coverage, then comes price. We have to get through the coverage conversations first. We do realize that this is a higher cost test, given we're doing whole genome every step of the way. Given what we believe about sequencing costs, what we believe about compute costs, we think we can make this an attractive at scale, adjusted EBITDA target of 25%, just like the rest of the business. We're going to have to flex, right? We're going to have to flex sales and marketing and R&D. Given the data-forward approach, we're going to effectively start at KOLs and then drive down. We expect the productivity of the sales team to not look that materially different.
We're not going to be going out there with hundreds of reps. We're going to be going out with a more concentrated team. On MIBC, we think 70% of those patients are already treated at the urologist's office. I actually think that in particular is going to be a really strong demonstration of this model. We wouldn't bundle necessarily, but we'll have more than—we'll have obviously our bladder classifier in the bag as well as the MIBC MRD product in the bag.
Great. We're out of time. We'll leave it at that. Thanks.
Thank you so much, Tim.